In a bid to tighten regulation of compounding pharmacies, the FDA issued draft guidelines this year that, among other things, would place restrictions on the amount of time that some drugs can be used by patients. Specifically, the agency would only permit a biologic medicine to be used more than five days after it has been repackaged by a compounder, if a study confirms the drug is protected.

The issue, however, is causing consternation, particularly when it comes to Avastin. The cancer medicine was never approved to treat age-related macular degeneration, a common affliction that can lead to blindness in the elderly, but the drug is widely used by ophthalmologists for this purpose. Why? Avastin can cost about $50 per injection, compared with $2,000 for Lucentis, which is approved for that use.

But Avastin vials must be repackaged for ophthalmologists. And Roche, which makes both drugs, has long argued the process – which is generally undertaken by compounders – could lead to safety issues, such as contamination. Although an analysis last year found Avastin is equally safe as Lucentis in treating AMD, the larger issue of patient safety resonates with the FDA.

Three years ago, an outbreak of fungal meningitis that led to 64 deaths was tracked to tainted products made by the New England Compounding Center. In response, Congress pressured the FDA to do more to exert its authority. As part of that effort, the FDA stepped up inspections and also issued new draft guidelines that, among many other things, placed restrictions on repackaging.

Now, though, two U.S. Senators have written the U.S. Department of Health & Human Services to raise concerns about the extent to which the draft guidelines would hamper use of lower-cost Avastin and, in the process, cost government health care programs more money. Both Senators – Susan Collins (R-Me.) and Claire McCaskill (D-Mo.) – are members of the Senate Committee on Aging.

“We were informed (by committee staff) that the costs to Medicare and to patients were not weighed by the FDA when measuring the effect of this draft guidance. While we understand that patient safety must come first, considering such an enormous impact on our Medicare system and on patient expenditures would be appropriate when considering the impact of this guidance,” they wrote in their letter to the HHS.

The senators also complain that the FDA failed to reach out to ophthalmologists to discuss what are called ‘beyond use dates’ in the draft guidance, since these physicians have “historically, adhered to much longer beyond use dates.” In fact, in comments submitted to the FDA in response to its draft guidance, the American Academy of Ophthalmology was upset with the proposed restrictions.

“The academy is seriously concerned about the proposed [dates] included in the draft guidance,” the group wrote, adding that the restrictions “will effectively eliminate access to the drug… The academy feels the agency did not present evidence in the draft guidance showing that the short intervals are necessary for patient safety, drug efficacy or that a longer beyond use date is inappropriate.”

Meanwhile, the senators want HHS to justify the restrictions in the draft guidance by forwarding all adverse event reports for Avastin and documents, among other things, that indicate how the draft guidance was compiled. An FDA spokesman says the HHS will respond directly to the senators but did not have any further comment.

We should note that the five-day repackaging restriction would shrink to as little as four hours if a compounder does not conduct studies that test for contamination or proper packaging. Also the restriction applies to outsourcing facilities, which are typically larger compounders that adhere to strict manufacturing standards, compared with more traditional compound pharmacies.

While supporting the increased testing proposed by the FDA, one consumer group agrees that a five-day beyond use date may not be sufficient.

A careful approach is correct because biologics are sensitive products and more susceptible to damage or contamination,” says Gabrielle Cosel, the manager of drug safety at Pew Charitable Trusts. “But outsourcing compounders should be allowed to set longer dates than the draft guidance would allow if they can support it with robust stability studies.”

Hello, everyone, and nice to see you again. We were away the past few days on what amounted to a long holiday weekend with one of our short people. Besides taking a needed break, creating memories can be important, yes? Now, though, we have returned to the usual routine of deadlines, meetings and the rest. And we cannot envision tackling all this without our ritual cup of stimulation. After all, there is a great deal to do. So please join us as we play a bit of catch up. Meanwhile, here are some tidbits. Hope you have a lovely day…

Sarepta Therapeutics stock surged in after-hours trading yesterday after the drug maker disclosed it can begin a rolling submissions process for FDA approval of its treatment for Duchenne muscular dystrophy, The Wall Street Journal reports. Sarepta plans to file this week a partial submission for approval of eteplirsen and then file the second part of its application by midyear. The news comes several weeks after former Sarepta ceo Chris Garabedian resigned amid ongoing tumult and questions about his dealings with the agency.

Johnson & Johnson has agreed to pay $7.75 million to the state of Arkansas, which had filed a lawsuit accusing the drug maker of improperly marketing its Risperdal antipsychotic and concealing its risks, a spokeswoman confirms. The settlement comes a year after the Arkansas Supreme Court struck down a judgment of nearly $1.2 billion against J&J under the state’s Medicaid Fraud False Claims Act. The court ruled the jury verdict and award could not stand because the state relied on the wrong law, covering health care facilities rather than drug makers, in its suit.

A top FDA official says the long lists of scary prescription drug side effects at the end of television ads are a waste of time for patients, according to Bloomberg News. The remarks come after the FDA last year began studying whether long lists of side effects in TV ads may cause viewers to overlook the most dangerous aspects of the medicine. An agency document about the study said it might be best to list only the most serious side effects and cover any lesser risks with a statement saying there are other potential harms.

The House Energy and Commerce committee pushed the markup and vote of the 21st Century Cures bill to Thursday at 8:30 a.m., just two hours before the committee was set to mark up the bill today at 10 a.m.

Amgen’s new cholesterol drug Repatha, which is a PCSK-9 inhibitor, could be recommended for approval in Europe as early as this week, putting it ahead in a race with a rival product from Sanofi, Reuters reports.

The New England Compounding Center, which was tied to a 2012 outbreak of fungal meningitis that killed at least 64 people, will pay $200 million to its victims and creditors under a bankruptcy reorganization plan approved yesterday, NBC News reports.

Valeant Pharmaceuticals is in talks to acquire Amoun Pharmaceuticals, one of the largest drugmakers in Egypt, to expand in both veterinary and human medicines, according to Bloomberg News.

The World Health Organization’s essential medicines committee rejected an application from Novartis to have Lucentis added to the list of drugs that should be stocked by all countries, The Guardian writes.

MannKind stock soared after a Jefferies analyst issued a report saying demand for Afrezza inhaled insulin should rise as more doctors become familiar with the device and a planned ad campaign begins later this year, The Los Angeles Times says.

A Johnson & Johnson biochemist testified that the drug maker never gave the FDA an internal analysis showing a link showing the Risperdal antipsychotic could cause boys to grow female breasts, New Brunswick Today reports.

The FDA lambasted two sterile compounders for violating good manufacturing practices in letters citing recent legislation brought in to ensure such companies are fully regulated, Outsourcing Pharma tells us.

The U.S. Federal Trade Commission charged the Cancer Fund of America, Cancer Support Services, the Children’s Cancer Fund of America and the Breast Cancer Society bilked donors across the country out of $187 million, The Washington Post writes.

The FDA approved a longer-acting version of the Invega Trinza antipscyhotic sold by Johnson & Johnson, writes Reuters, adding the drug can be administered just four times a year, the longest dosing interval available for treating schizophrenia.

Twelve days into a jury trial in federal court in a gender and pregnancy discrimination suit by a former executive, Merck claims the plaintiff has failed to demonstrate a right to reinstatement after her pregnancy leave, The New Jersey Law Journal writes.

GlaxoSmithKline failed to win an injunction to prevent Rowex from selling a product that is similar in packaging and color to its Seretide inhaler, according to The Irish Times.

Perrigo’s chief executive said there is a price at which deal talks with Mylan could happen, although the current bid is nowhere near there, Bloomberg News reports.

Once again, the FDA has taken a tough stance against a compound pharmacy with quality-control problems that led to product recalls and concerns over patient safety. In this latest instance, the agency obtained a consent decree that prohibits Specialty Compounding from making or distributing injectable sterile medicines until the company complies with federal law governing manufacturing practices.

The move comes after FDA inspectors found unsanitary conditions, bacterial contamination and numerous manufacturing violations at the compounder. The inspection stemmed from complaints by two hospitals that 17 patients developed infections after being treated with medicines made by the compounder. The compounder recalled the medicines and vowed to correct the problems.

A spokesman for the compounder, which is based in Cedar Park, Texas, stopped making sterile medicines in 2013 and has since invested $25 million, including a new sterile lab. The compounder, which still makes other medicines, hopes to resume production of sterile medicines after the FDA conducts an inspection. It is not clear when that may occur because FDA inspections are typically unannounced.

This marks the fourth time that the FDA has taken aggressive action against a compound pharmacy in the past two years. The agency has been aggressively scrutinizing compounders since a 2012 outbreak of fungal meningitis that killed 64 people was traced to the New England Compounding Center in Massachusetts. More than 750 people in 20 states contracted meningitis from tainted steroids.

The episode was called the worst public health crisis in decades and cast a harsh spotlight on the FDA and the extent to which the agency properly exercised its available authority. In response, Congress passed a law called the Drug Quality and Security Act that bolstered FDA oversight. The agency, meanwhile, has inspected dozens of compounders nationwide.

The increased oversight has, so far, resulted in a few serious enforcement actions.

Last month, a 37-count indictment charged a New Jersey compounder, as well as its owner and chief pharmacist, with wire fraud and violations of the Food, Drug & Cosmetic Act for selling adulterated and misbranded drugs. Last December, a compounder in Tennessee and its owner each pleaded guilty to a misdemeanor for selling adulterated medicines with bacterial contamination.

Meanwhile, the owner and head pharmacist at the New England Compounding Center and its supervisory pharmacist were charged with 25 acts of second-degree murder, among other things; and 12 others were charged with additional crimes, including several violations of the Food, Drug & Cosmetic Act, according to federal authorities.

A spokesman for the International Academy of Compounding Pharmacists, a trade group, expressed concern about the string of consent decrees. “The consent decree is a necessary enforcement tool for the FDA and we do not object to its use. A consent decree can serve as a basis for the government and a pharmacy to agree on steps that must be taken to assure safety and resume production,” he says.

“What does concern IACP is the way these agreements, when reached with compounding pharmacies, are publicized because it appears they are publicized by FDA much more broadly than enforcement actions involving drug makers,” he continues. “They seem intent on raising broad public concern about compounding, rather than on informing the public about one particular pharmacy or agreement.”

We asked the FDA for comment and will update you accordingly. Meanwhile, Gabrielle Cosel, manager of drug safety at Pew Charitable Trusts, says that, “following the major outbreak of meningitis in 2012 and 2013, FDA’s ongoing vigilance in this space is not only appropriate it is essential.”

[UPDATE: An FDA spokeswoman later sent us this: "The FDA is very concerned about compounding practices that violate federal law, particularly when such practices may result in the introduction of bacterial contamination into sterile injectable drugs and may cause serious adverse events in patients. The FDA routinely issues press releases when a consent decree is entered against any company, regardless of the nature of its operations."]

In 2012, an outbreak of fungal meningitis that was traced to a compound pharmacy led to 64 deaths and what officials called the worst public health crisis in the U.S. in decades. Ever since, legislators and regulators have paid closer attention to compound pharmacies in hopes of bolstering the pharmaceutical supply chain and avoiding another tragedy.

A new report, however, suggests there are still gaps in oversight. The organizations that review hospitals participating in Medicare fail to sufficiently examine contracts with compound pharmacies, according to a new report by the Office of Inspector General in the U.S. Department of Health & Human Services. The OIG says contract reviews are needed to ensure the safety and quality of the medicines.

The implications are potentially significant. As the report notes, compounded sterile medications are higher risk products that are generally administered to patients through injection or infusion, and preparation requires more expertise and more extensive safety measures. And hospitals tend to outsource the highest risk compounded sterile preparations, rather than make them on their premises.

Among hospitals that participate in Medicare, 92% use compounded sterile preparations. Of these, almost 80% contract with at least one standalone compounding pharmacy to provide these medications, according to the report. Yet only one of five oversight entities always reviews hospital contracts with standalone compounders and assesses whether hospitals evaluate compliance with contracts.

In its report, the OIG noted that five entities provide such oversight – the Centers for Medicare and Medicaid Services, as well as four organizations that accredit hospitals for participation in Medicare: the Joint Commission, the American Osteopathic Association, Det Norske Veritas Healthcare and the Center for Improvement in Healthcare Quality.

The OIG focused on a check list of nearly a dozen recommended – but not required – oversight steps for contract review. High on the list is whether hospitals are signing contracts with compounding pharmacies that are registered with the FDA.

Registration is a contentious issue. Partly in response to the meningitis outbreak, a law was passed in late 2013 that created two classes of compounders. One group voluntarily registers with the FDA and must follow so-called good manufacturing practices. The agency hopes added requirements will give hospitals and physicians the confidence to purchase medicines from these compounding pharmacies.

In effect, by registering as outsourcing facilities, as the FDA calls them, these pharmacies obtain something akin to a Good Housekeeping seal of approval. So far, 41 compound pharmacies have registered with the FDA, several of which have previously received warning letters from the agency for various infractions, according to this list.

In response to the report, outgoing CMS administrator Marilyn Tavenner wrote a letter to the OIG to say she largely agrees with the recommendations and plans to bolster oversight, although she notes that hospitals that participate in Medicare are not required to contract only with compounding pharmacies that register with the FDA.

Meanwhile, Richard Curtis, who is chief executive at the Center for Improvement in Healthcare Quality, says that, “at this point, we’re waiting to see how CMS will operationalize the OIG recommendations so that we can adjust appropriately. I think it’s safe to say that all of the accrediting organizations will be increasing the amount of resources and time allocated to assessing compounding practices in hospitals.”

And Robert Juhasz, president of the American Osteopathic Association, sends a statement saying that reviewing contracts “can be a step in approaching the situation, but hospitals rely on the data provided by these companies in a review of quality and performance. It is not feasible for [hospital] staff to observe practices in a compounding pharmacy that is, potentially, hundreds of miles from their facility.

“Unless mandatory federal requirements are legislated and monitored, the public cannot be assured that the compliance is consistent,” he adds. He also argues the OIG report “failed to reflect” the percentage of sterile medicines purchased by physician offices, and cancer and dialysis centers. “Regulatory changes for hospitals will not impact compliance” with these providers, he says. “This places the burden on CMS to develop requirements at the compounding pharmacy level” to bolster safety.

We also asked the Joint Commission and Det Norske Veritas Healthcare for comment and will update you accordingly.

[UPDATE: Patrick Horine, chief executive at Det Norske Veritas Healthcare, called to say that "we do look at the contracts and we do have an evaluation method. But can more be done? Yes, there’s always more that can be done."]

Fourteen former owners or employees of the New England Compounding Center were charged in connection with a 2012 meningitis outbreak that killed 64 people nationwide and was traced to tainted drug injections made by the pharmacy, according to a federal indictment.

The most serious charges were made against Barry Cadden, a co-founder, and Glenn Chin, a supervisory pharmacist who oversaw the sterile room, who were charged with 25 counts of second-degree murder for causing the deaths of patients in seven states. Cadden and Chin face a maximum of up to life in prison if convicted on all counts. Their attorneys did not respond to requests for comment.

More than 750 people in 20 states contracted fungal meningitis from tainted steroids that were made by the pharmacy, which was based in Framingham, Mass. The outbreak was called the worst public health crisis in the U.S. in decades and prompted Congress to pass a law, the Drug Security & Quality Act, that gives the FDA greater oversight in regulating compound pharmacies.

The feds allege that NECC employees were aware that the steroids were made in an “unsafe manner and in insanitary conditions.” They “knew they were producing their medication in an unsafe manner and in insanitary conditions, and authorized it to be shipped out anyway, with fatal results,” Attorney General Eric Holder says in a statement. The indictment notes, for instance, that drugs were shipped containing expired ingredients (here is the 73-page indictment).

[UPDATE: An attorney for Cadden later sent us this: "The indictment announced today by the U.S. Attorney seeks to transform this tragic accident into a federal crime. And it does so amid troubling uncertainties. To this day, we do not know how the particular vials of drugs that triggered this tragedy got contaminated. We do not know why they got contaminated. And we do not know who caused their contamination. Not every accident, and not every tragedy, are caused by criminal conduct.

"The U.S. Attorney’s office has exploited this indictment to wage a public relations campaign trumpeting its actions. This type of public spectacle should have no place in the American justice system. The U.S. Attorney’s Office should not indict people over the tragic consequences of non-criminal conduct. And it should not wage a public relations campaign to vilify citizens who have been found guilty of nothing."]

A total of 14 people, including six other pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two NECC owners, and one other individual were charged with additional crimes including racketeering, mail fraud, conspiracy, contempt, structuring, and violations of the Food, Drug and Cosmetic Act.

The indictment also alleges that other NECC pharmacists knowingly made and sold numerous drugs in an unsafe manner and in insanitary conditions. This included failing to properly test drugs for sterility and failing to wait for test results before sending drugs to customers. The pharmacy also failed to properly maintain clean premises or respond when environmental monitoring detected mold and bacteria in clean rooms used for production.

The feds also allege that NECC “repeatedly” attempted to avoid FDA oversight by claiming to be a pharmacy dispensing drugs to individual patients with valid prescriptions when, in fact, bulk shipments were sent to customers, such as clinics, without valid prescriptions. The indictment also maintains NECC used phony names, including those of celebrities, on some fake prescriptions.

The indictment also charges Carla Conigliaro, the majority NECC shareholder, and her husband, Douglas Conigliaro, with transferring assets after the outbreak and after they were ordered not to do so following a 2012 bankruptcy filing by the pharmacy.

Those assets included about $33.3 million that was transferred to eight different bank accounts that were opened after the NECC bankruptcy, according to the feds. The Conigliaros were ordered to forfeit numerous assets. Their attorneys did not respond to requests for comment.

And so, another working week will soon draw to a close. Not a moment too soon, yes? Normally, we would take this opportunity to indulge our fantasies about weekend plans, but we have other matters on our mind today. Unfortunately, there was a death in the Pharmalot family, so we will be rolling in the sidewalks on the early side. Nonetheless, we hope you have pleasant plans for the weekend respite. In some parts, this is a lovely time of year to start gathering apples or pumpkins. You could take a drive in the country. Maybe get some exercise by taking a long constitutional. Or simply hit the pause button and count your blessings. Whatever you do, have a grand time. But be safe. See you soon…

Akorn is exploring a bid for UCB’s U.S. subsidiary in a deal that would allow the company to move its tax domicile overseas in a practice known as a tax inversion, according to Reuters. The specialty generics subsidiary, known as Kremers Urban Pharmaceuticals, could fetch as much as $2 billion. Akorn, which is based in Illinois, has a 37% tax rate, while UCB is based in Belgium and its subsidiary is based in New Jersey.

Sun Pharmaceuticals faces some fresh manufacturing challenges. The Indian generic drug maker received a surprise visit from FDA inspectors at its Halol plant in Gujarat, according to The Hindu Business Line. And its Taro subsidiary is recalling its leading blood clot drug from the market after the FDA found that the product did not meet quality standards, according to The Economic Times, which notes this is the third recent product recall that Sun has undertaken.

An FDA advisory committee voted 14-to-1 to recommend a Novo Nordisk injectable medication for treating diabetes, which is currently marketed as Victoza, as a weapon in the war against obesity, Bloomberg News writes.

A Boston-area pharmacist pleaded not guilty to a charge stemming from the deadly 2012 U.S. meningitis outbreak, a week after he was arrested attempting to board a flight to Hong Kong, Bloomberg News reports.

More than 35 percent of Allergan investors have asked the company to call a special meeting, handing a victory to billionaire investor William Ackman who is trying to broker a sale of the Botox maker to Valeant Pharmaceuticals, writes Reuters.

Baxter International has named the biopharmaceutical business it intends to spin out next year as Baxalta, which is a combination of Baxter and ‘alta’, a derivative of the Latin word ‘altus’ which means high or profound, says PM Live.

The U.K.’s Medicines and Healthcare products Regulatory Agency says Twitter, Facebook and smart phone apps could soon be used to gather adverse drug reactions, according to InPharma Technologist.

The mobile health market may still be in its infancy, but close to 100 million wearable remote patient health monitoring devices will be shipped over the next five years, MedCity News tells us.

India’s National Pharmaceutical Pricing Authority is warning drug makers they face penalties if they fail to maintain minimum production levels of essential drugs, according to PharmaBiz.

Good morning, everyone, and how are you today? Clouds are hovering over the Pharmalot campus, but our spirits remain sunny. After all, who can forget what the Morning Mayor would say – ‘Every brand new day should be unwrapped like a precious gift.’ Sage advice is always welcome here. So while you tug on the ribbon, we will brew another cup of needed stimulation – we are back to Blueberry Cobbler – and get on with things. And so, here are some fresh tidbits. Hope your day is smashing and do stay in touch…

For the third time in two years, the FDA has approved a diet pill. The agency late yesterday endorse Contrave, which will be sold by Orexigen Therapeutics and Takeda Pharmaceutical. The drug will compete with Belviq from Arena Pharmaceuticals and Eisai, and Qsymia, which is marketed by Vivus. The FDA is requiring Orexigen to perform a cardiovascular outcomes trial and two safety and efficacy trials in pediatric populations. Although public health officials have noted obesity is a growing problem, Bloomberg News notes that Medicare and Medicaid do not pay for diet drugs and only 50 percent of people with private insurance receive coverage.

In a letter sent to Allergan directors, Pershing Square’s William Ackman wrote that rebuffing the bid that he and Valeant Pharmaceuticals have made for the Botox drug maker “has wasted corporate resources, delayed enormous potential value creation for shareholders, and are professionally and personally embarrassing for you. The smell of strong brew is in the air, now is the time to wake up.” The letter was released in a regulatory filing, Reuters notes.

The first person to face criminal charges linked to a 2012 U.S. meningitis outbreak that killed 64 people and sickened 700 in 20 states is due in court today to respond to claims that he knowingly shipped a tainted medication, according to Reuters. Glenn Adam Chin, 46, a former pharmacist at the now-defunct New England Compound Company, which produced the tainted steroid that sparked the outbreak, was arrested last week as he boarded a flight to Hong Kong for a family wedding.

A Chinese drug maker received approval from China’s State Food and Drug Administration to become the country’s first official producer of a homegrown version of Viagra, Pfizer’s famous erectile dysfunction drug, The New York Times says.

European regulators approve the use of Eli Lilly and Boehringer Ingelheim’s basal insulin Abasria, which has the same amino acid sequence as Sanofi’s blockbuster Lantus, Pharma Times writes.

The FDA approved the use of Medivation and Astellas Pharma 's advanced prostate cancer drug Xtandi in men who have not yet received chemotherapy, significantly expanding the potential patient population for the oral medicine, according to Reuters.

India’s National Pharmaceutical Pricing Authority plans to work with state governments to establish price inspectors throughout the country to work with local regulators to track price changes and compliance with cost controls, The Business Standard says.

A three-year project led by the U.K.’s Medicines and Healthcare Products Regulatory Agency seeks to develop a mobile application to gather and report adverse drug reactions, according to In-Pharma Technologist.

FDA reviewers say NPS Pharmaceutical’s Natpara hormone replacement therapy reduced the need for calcium and vitamin D supplements in clinical trials, though data from one trial site was excluded due to manufacturing violations, Reuters writes.

A Wockhardt facility that was already banned from sending product to the U.S. was inspected this week by the U.K.’s Medicines and Healthcare Products Regulatory Agency, The Business Standard writes.

FDA officials have asked a compounding pharmacy with which they have repeatedly sparred to recall all of its sterile products over concerns that medicines that are currently circulating may be contaminated and present a risk of illness or injury, according to a letter sent yesterday to Downing Labs, which operates NuVision Pharmacy in Dallas, Texas.

The move comes after the FDA found a host of problems during an inspection earlier this summer and warned health care providers and consumers not to use the medicines made by the compounder. In fact, this was the third such warning in 15 months that the agency issued about NuVision and the safety of its compounded drugs.

“Given the high rate of contamination, there is a high probability that contaminated units from other purportedly sterile drug product lots produced at the Downing Labs facility are currently in distribution,” the FDA wrote in what the agency calls a ‘formal request.’ “Based on the inspectional findings, FDA has serious concerns about the conditions and practices at the facility for the production of sterile drugs, which result in a lack of sterility assurance.”

The letter goes on to cite various manufacturing problems, such as a lack of “sound scientific data” to support explanations for sterility failures and an inability to identify the cause of the sterility failures. The FDA also noted vials containing fibers and particles were culled from 184 lots of supposedly sterile drugs, but only visual exams took place and there was no investigation to determine the cause.

We asked NuVision for comment and will update you accordingly.

As we have written previously, the FDA issued alerts twice last year about sterility problems; NuVision recalled one product. And a year ago, the agency tried unsuccessfully to persuade the compounder to recall still more products and NuVision responded by posting a notice on its website saying it did not qualify as a drug manufacturer and so was not required to follow FDA standards for manufacturing.

Some background from an earlier post: The defiant posture taken by NuVision was cited last year by the FDA as further need for Congress to pass legislation that would allow the agency to bolster its regulatory oversight and legal options when encountering recalcitrant compounders. At the time, the FDA was defending its actions in the wake of an outbreak of fungal meningitis in 2012 that was tied to a compounded and caused dozens of deaths.

In response, the Drug Quality and Security Act was passed to, in part, bolster compounding oversight. The law creates two classes of compounders. One group voluntarily registers with the FDA and must follow so-called good manufacturing standards. The agency hopes added requirements will give hospitals and physicians the confidence to purchase medicines from such compounders (here is the list).

Such an imprimatur is designed to act as an incentive that could boost compounding orders at the expense of those that do not register and lack such a designation. Just the same, those compounders that do not register, such as NuVision, are still subject to warning letters, product seizures, injunctions and, possibly, criminal violations for distributing contaminated products, according to an FDA guidance.

State boards of pharmacy are expected to provide added oversight of this group. We asked the Texas Board of Pharmacy if they took any recent action or planned any against NuVision and will provide you with any response.

Good morning, everyone, and how are you today? The middle of the week is here, which means your survival skills are intact – so far. To celebrate, and to stay on track, you may want to reach for a cup of stimulation. We have already enjoyed a mug of Golden French Toast, for those interested in a little experimentation. Now, though, the time has come to get busy. So here are a few items of interest to get you started. So dig in and have a smashing day. And one other thing – do keep us in mind if you run across anything intriguing. As always, we accept confidential stuff and enjoy hearing secrets…

The Broad Institute, a biomedical research center, announced a $650 million donation for psychiatric research from the Stanley Family Foundation — one of the largest private gifts ever for scientific research. And The New York Times writes the money comes at a time when basic research into mental illness is sputtering, and many drug makers have all but abandoned the search for new treatments. The announcement was timed to coincide with publication of the largest analysis to date on the genetics of schizophrenia.

A Turkish man pleaded guilty yesterday to smuggling counterfeit, adulterated and misbranded cancer drugs into the U.S., including a version of the Avastin cancer drug that is not approved for sale in the U.S., The Wall Street Journal informs us. Ozkan Semizoglu, who worked for a Turkish drug wholesaler, smuggled the cancer drugs to the U.S. in small parcels that were falsely labeled as “gifts,” according to a copy of his plea agreement filed in U.S. federal court in the Eastern District of Missouri in St. Louis. The two counts of smuggling to which he has pleaded guilty carry maximum prison sentences of five and 20 years.

Celgene is battling allegations in court of improperly promoting its Thalomid cancer drug for uses not approved by regulators. And the big biotech will now have to continue the battle after a federal judge refused to dismiss a False Claims Act lawsuit filed by a former saleswoman, Bloomberg News conveys. The case has drawn attention because it raises important questions about when and how manufacturers may encourage doctors to prescribe medications for uses that haven’t been specifically approved by the FDA.

After posting a healthy set of financials for the first half of the year, and being mentioned by many as a takeover target, Actelion says its portfolio and pipeline mean that independence is the right path, Pharma Times reports.

AstraZeneca is casting its net wider in the hot cancer immunotherapy field through a clinical trial collaboration with U.S. biotech firm Advaxis that will test drugs from both companies in combination, according to Reuters.

Sales reps are experiencing even more limited physician access, partly due to consolidation among physicians and other health care providers, Medical Marketing & Media tells us.

Using laminated particleboard in aseptic processing areas is really not such a good idea, the FDA tells a compounding pharmacy in a warning letter, Regulatory Focus writes.

Strides Arcolab received FDA approval to market an immuno-suppressant used for preventing organ rejection in certain patients following liver, kidney, or heart transplant, The Economic Times says.

Puma Biotechnology shares almost tripled in extended trading after the company said a clinical trial of its experimental drug blocked the return of breast cancer in women with a type of early-stage disease, Bloomberg News writes.

For the third time in 15 months, the FDA is warning health care providers and consumers not to use drugs that were made by a Dallas compounder because the medicines may be contaminated. And the ongoing struggle between the agency and NuVision Pharmacy underscores the difficulties that beset the pharmaceutical supply chain despite a recently passed law designed to bolster safety.

In an alert issued late last week, the FDA took the unusual step of including a link to a 15-page inspection report that was completed July 16, showing numerous instances in which NuVision failed to investigate batches of various medicines after finding sterility problems. The FDA noted in its alert that these medicines had been marketed to the public as ‘sterile.’

The inspection follows two similar FDA alerts issued in April and May of last year about sterility problems with NuVision medicines. NuVision recalled one product. Last July, the FDA tried unsuccessfully to persuade NuVision to recall still more products. But NuVision defiantly posted a notice on its web site saying that it did not qualify as a drug manufacturer and was not required to follow FDA standards for manufacturing.

We left messages at NuVision seeking comment about the latest FDA alert and will update you with any reply that we receive.

The NuVision posture was cited last year by the agency as further need for Congress to pass legislation that would allow the FDA to bolster its regulatory oversight and legal options when encountering recalcitrant compounders. The FDA, at the time, was defending its actions in the wake of an outbreak of fungal meningitis in 2012 that was tied to a compounder and caused dozens of deaths.

The episode was called one of the worst public health crises in the U.S. in decades and cast a harsh spotlight on the FDA and state regulators, and the extent to which they properly exercise their available authority. Last fall, after months of recriminations, President Obama signed the Drug Quality and Security Act, which includes a section devoted to compounding oversight.

The law, effectively, creates two classes of compounders – one that voluntarily chooses to register with the FDA and another that may decline to do so. The first group is subject to certain conditions, such as meeting so-called good manufacturing standards, but the FDA hopes that the added requirements will give hospitals and physicians the confidence needed to purchase medicines from such compounders.

An FDA spokesman says that NuVision did not register with the FDA (here is the list). Even so, such compounders are still subject to warning letters, product seizures, injunctions and, possibly, criminal prosecution for violations of the Food, Drug & Cosmetic Act for distributing contaminated products, according to a recently issued FDA guidance on compounding.

And state boards of pharmacy are expected to continue to provide oversight. Gay Dodson, the executive director of the Texas Board of Pharmacy, tells us her agency has not taken any action against NuVision, but “we know what they’re finding.” She declined to comment when asked whether the board would investigate in light of the most recent FDA alert.

The flap is evidence that, while the law may give FDA added oversight, the voluntary nature of the registration process also means that cornering wayward compounders remains challenging.

“We’re still undergoing change says Gabrielle Cosel, manager of drug safety at Pew Charitable Trusts. Some compounding facilities will join that first category and others will change their business models and some other facilities will get into disagreements with FDA over what is allowed and what isn’t. This will have to shake out over time. A lot of work has to be done, but a lot of groundwork is in place.”